~A-CN-91/86

UNITED STATES ENERGY EMPLOYEES OCCUPATIONAL ILLNESS

COMPENSAnON PROGRAM: ADJUDICAnON OF RADIATION-RELATED

CANCER CLAIMS UTILIZING DOSE RECONSTRUCnON AND PROBABILITY OF

CAUSATION PROCEDURES.

L. J. Elliott, T. Katz, J. Neton, M. Schubauer-Berigan

The National Institute for Occupational Safety and Health (NIOSH), United States of America,

e-mail tiel@cdc.gov.

Abstract

The United States (U.S.) nuclear weapons production workforce has recently been provided a

compensation program, which covers claiIns concerning radiation-related cancer as determined

by individual dose reconstruction and probability of causation guidelines. This paper provides

information on the background, purpose, and implementation philosophy of this new

compensation program. Companion papers describing the probability of causation and dose

reconstruction guidelines for this program have also been submitted to the Conference.

1. Background

In October 2000 the United States' Congress passed the Energy Employees Occupationalll1ness

Compensation Program Act (EEOICPA), P.L. 106-398 §§ 3623(b) and (d-e) I. On December 7,

2000, the President issued E.O. 13179 assigning several policymaking and technical roles under

EEOICP A to the U.S. Department of Health and Human SelVices (IniS), including

promulgation of two regulations central to the adjudication of cancer-related claims!

The first of these roles, 42 CFR Part 81, establishes guidelines to detennine whether an

individual with cancer shall be found "at least as likely as not" to have sustained that cancer

from exposure to ionizing radiation in the performance of duty for nuclear weapons production

programs of the U.S. Department of Energy (DOE) and its predecessor agencies.3 These

"probability of c~~~tion" guidelines will be used for the adjudication of cancer claims by the

U.S. Department of Labor (DOL), which has lead responsibility to administer this federal

compensation program.

The second of these roles. 42 CFR Part 82 . establishes the methods by which IllIS will estimate

the doses of radiation incurred by individual employees of nuclear weapons production

programs.4 These methods of ~'dose reconstruction" will be used by the National Institute for

Occupational Safety and Health (NIOSH), Centres for Disease Control and Prevention (CDC).

NIOSH is named under EEOICP A to assist the Secretary of IffiS to implement his

responsibilities under the Act. NIOSH will provide the dose reconstruction results to claimants

and to DOL. which will use the results to detennine probability of causation. DOL. which has

promulgated its administrative procedures under EEOICP A . will use the IllIS regulation on

probability of causation and the NIOSH generated dose reconstructions to adjudicate an

estimated 40.000-50.000 cancer claims expected through FY 2005.

NIOSH obtained the views of a diverse cross-section of prominent scientific experts, program

officials, and of representatives of the public who will be affected. The relevant scientific fields

and compensation precedents have been thoroughly researched and applied with careful

attention to the unique needs of this particular compensation program. The resulting interim

rules are fair, reasonable, and grounded in the best available science. We also believe they

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effectively and efficiently implement the directions and intent of Congress, as stated in

EEOICPA.

2. Discussion

Approximately 650,000 nuclear weapons production workers have been employed by DOE and

its principal contractors since the inception of these programs in the 19405. In addition, as many

as 100,000 workers may have been employed in production in the first decades of these

programs by short-tenD contractors of DOE, referred to under EEOICP A as Atomic Weapons

Employers. EEOICPA was enacted after research indicating associations between work-related

exposures to potential hazards and elevated rates of cancers and other illnesses incurred by this

workforce. As one of the remedies, EEOICP A mandated federal compensation including

$150,000 in lump-sum payments and the provision of medical coverage for surviving workers

found to have incUlTed cancer, beryllimn disease, or silicosis resulting ftom their service to the

United States in nuclear weapons production.

The two IlliS regulations provide a fair, reasonable, and science-based approach by which DOL

would deteImine the probability of cau.~tion for cancer claims under EEOICP A and by which

NIOSH would provide assistance by conducting dose reconstructions for individual cancer

claimant.q. The regulations build upon methods used by the U.S. Defense Threat Reduction

Agency (DTRA) and the U.S. Department of Veterans Affairs (DV A). These agencies,

respectively, conduct dose reconstructions and detennine probability of causation for cancer

claims for Atomic Veterans - veterans and Department of Defense civilian employees exposed

to radiation at nuclear test sites and during wwll. The IffiS rules extend beyond these

precedents as necessary to address the unique radiation exposure and disease experiences of

nuclear weapons production workers and to implement the expressed directions of Congress in

EEOICP A.

The probability of causation guidelines rely heavily upon the cancer risk models used by the

DV A, called the "Radioepidemiological Tables." These cancer risk models were originally

developed by a National Institutes of Health (NnI) committee and have been updated by a joint

workgroup of the National Cancer Institute and CDC. The update takes the fonn of a computer

program rather than a set of printed tables, and is called the Interactive Radioepidemiological

Pro~ or IREP. NIOSH worked with the NCI to help bring the update to completion and add

risk models for bone cancer and for lung cancer associated with exposure to radon. These

additional cancer models address exposures uniquely incuned by nuclear weapons production

workers. NIOSH independently incorporated additional changes with particular importance for

claims under EEOICP A, such as risk models for skin cancers and adjustments to risk models to

account for unique types of radiation exposures. These additional changes were produced in a

unique version of IREP specifically intended for use by DOL in adjudicating claims under

EEOICPA, and is identified as the NIOSH-IREP.

The other important innovation of the IlliS probability of causation guidelines is to implement

systematic objective procedures for handling claims with unusual characteristics. This is

essential to achieve consistent and efficiently rendered decisions, particularly b~-aU-~ of the

high claims volume expected. The principal example of this innovation is the handling of

claims for secondary cancers, when the primary site of cancer cannot be identified in available

records. DV A handles these on an ad-hoc basis by a program expert making case-by-case

judgments for assigning the primary site of cancer. The HIlS regulation provides DOL with an

objective procedure for making such decisions. Other types of claiIns that involve unusual

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characteristics requiring such procedures include those involving certain cancers for which we

lack a single, optimal cancer risk model, and claims involving multiple primary cancers.

The JffiS regulation on dose reconstruction uses methods similar to those applied by DTRA.

These methods are based on standard approaches of this research field but achieve efficiency by

substituting scientific, reasonable, and fair assumptions in the place of extensive data collection.

The trade-off of reduced precision of dose estimates for increased processing efficiency is

essential for an effective compensation program, since claimants cannot await the months to

years of data collection that a dose reconstruction might otherwise require, if conducted for the

purpose of research. NIOSH methods include measures to achieve additional efficiency~

because the data collection burden and expected volume of claims under EEOICP A are far

greater than those experienced by DTRA. Thus, the NIOSH methods also include a triage

approach to husband resources for claims in which increased precision of the results is important

and to speed the conclusion of dose reconstructions for claims whose outcomes would not be

affected by increased precision.

The other important innovation of the IrnS dose reconstruction rule is the systematic inclusion

of the claimant in the dose reconstruction process. The claimant is essential as an inforDlational

resource, because of the greater complexity of radiation exposures and the variability of

radiation safety practices and records, compared with the situation for Atomic Veterans. DTRA

indicated strong support for such an approach. While DTRA only involves claimants on an ad

hoc basis, they find this involvement to be critical to establish the trust and understanding of the

claimants. Establishing trust and understanding are particularly important with respect to

nuclear weapons production workers because of their widespread distrust of DOE in matters

concerning occupational radiation exposures and health.

Of final note on the content of the mIS rules, both include provisions that allow NIOSH to

update scientific elements of the guidelines and methods without the promulgation of revised

rules. These are necessary to allow the compensation program to remain current with important

advances in science that affect either probability of causation detenninations or dose

reconstructions. Any updates of either mIS regulation proposed by NIOSH would be published

for public comment and obtain the review of the Advisory Board on Radiation and Worker

Health.

Prior to drafting the regulations, NIOSH obtained the individual views of experts, directly

affected individuals, and interested parties. These included DOE contractors, organized labor

representatives of nuclear weapons production employees, the employees themselves, fed~

agencies and their contractors involved in the compensation program for Atomic Veterans,

experts in health physics and cancer research, and the federal agencies involved in implementing

EEOICP A. NIOSH expected the HHS rules to be received as consistent with mainstream views

from each of these perspectives.

IlliS has reviewed budget projections related to the promulgation and implementation of these

two :m:IS rules. The most substantial costs will be incurred in conducting the :m:IS program of

dose reconstructions. We expect at some point these regulations may face legal challenges

based on procedural and substantive grounds. Legal challenges are unlikely to occur before

DOL renders final decisions denying cancer claims for which dose reconstructions were

conducted. This will likely be late summer or early fall of2002. Before then, DOL must review

and verify eligibility of claims, request dose reconstructions from NIOSH for qualified claims,

obtain completed dose reconstructions from NIOS~ calculate probability of causation, issue

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recommended decisions to claimants, respond to requests by claimants for administrative review

of recommended decisions (including obtaining NIOSH reviews of completed dose

reconstructions), and render final decisions. This period before final denials are rendered

provides reasonable opportunity for the Advisory Board on Radiation and Worker Health to

conduct its technical review of the probability of causation guidelines and its evaluation of the

quality of dose reconstructions.

References

[1]

[4]

The Energy Employees Occupational illness Compensation Program Act, Public Law

106-398, 114 Stat. 1654, 1654A-1231 (October 30.2000). enacted as Title XXXVI of the

Floyd D. Spence National Defense Authorization Act for Fiscal Year 2001.

Executive Order 13179, Providing Compensation to America's Nuclear Weapons Workers

(65 FR 77487), December 7, (2000).

Probability of Causation Guidelines Under the Energy Employees Occupational illness

Compensation Program Act of 2000, proposed for promulgation at 42 CFR 81 (66 FR

50967), October 5, (2001).

Methods for Radiation Dose Reconstruction Under the Energy Employees Occupational

illness Compensation Program Act of2000, proposed for promulgation at 42 CFR 82 (see

66 FR 50978), October 5, (2001).

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